New Zealand Gazette – 2013 – No. 13

Page 450

✨ Medicine Classifications

450 NEW ZEALAND GAZETTE, No. 13 7 FEBRUARY 2013

Product:
Tripacel

Active Ingredients:
Diphtheria toxoid, adsorbed 30IU
Pertactin 3mcg
Pertussis filamentous haemagglutinin 5mcg
Pertussis fimbriae 2+3 5mcg
Pertussis toxoid, adsorbed 10mcg
Tetanus toxoid, adsorbed 40IU

Dosage Form:
Suspension for injection

New Zealand Sponsor:
sanofi-aventis new zealand limited

Manufacturer:
Sanofi Pasteur Limited, Ontario, Canada

Dated this 31st day of January 2013.

Dr DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
(pursuant to delegation given by the Minister of Health on 6 July 2001).

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Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981, I, Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health, acting under delegated authority, hereby declare the following:

The medicines listed in Schedule 1 to this notice are classified as prescription medicines.
The medicines listed in Schedule 2 to this notice are classified as restricted medicines.
The medicines listed in Schedule 3 to this notice are classified as pharmacy-only medicines.

Every reference to a medicine in this notice applies whether the medicine is synthetic in origin or is from biological or mineral sources.

Unless specific reference is made otherwise, every reference applies also to medicines that are:

(a) preparations and admixtures containing any proportion of any substance listed in the notice.

(b) salts and esters of any substance listed in the notice.

(d) salts or oxides of elements listed in the notice.

Unless specific reference is made otherwise, every reference to a medicine applies:

(i) if the medicine is in an injection or eye preparation, to any concentration of that medicine; and

(ii) if the medicine is not in an injection or eye preparation, only if the concentration of the medicine is greater than 10 milligrams per litre or per kilogram.

Where any reference is modified by a statement of the strength of the medicine, the strength is calculated using the free acid, base, alcohol or element unless specifically stated otherwise.

Schedule 1

Prescription Medicines

Abiraterone acetate
Axitinib
Cobicistat
Elvitegravir
Febuxostat

Schedule 2

Restricted Medicines

Adrenaline; in medicines containing 1% or less except in medicines for injection containing 0.02% or less
Ciclopirox; for external use in medicines containing more than 2%; in preparations for application to the nails containing more than 8%
Influenza vaccine; except when administered to a person 18 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health
Oseltamivir; except when specified elsewhere in this notice
Oseltamivir; in solid dosage forms for oral use containing 75 milligrams in a pack size of up to 10 dosage units for the treatment or prophylaxis of influenza in adults and children aged 13 years and older who have been exposed to the influenza virus
Vilanterol

Schedule 3

Pharmacy-only Medicines

Ciclopirox; for external use in medicines containing 2% or less except when for the treatment of tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board; in preparations for application to the nails containing 8% or less

Medicines for General Sale

Please note that the following medicines are now available for general sale.

Adrenaline; in medicines for injection containing 0.02% or less
Ciclopirox; for external use in medicines containing 2% or less when for the treatment of tinea pedis only or when sold in practice by a podiatrist registered with the Podiatrists Board

Dated this 30th day of January 2013.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health.

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Gazette.govt.nz — NZ Gazette 2013, No 13

The General Assembly Library (on the right) was completed in 1899 and survived the 1907 fire. Now the oldest remaining original Parliament building, still used as the Parliamentary Library.

✨ LLM interpretation of page content

🏥 Consent to the Distribution of Tripacel (continued from previous page)

Domain🏥 Health & Social Welfare
Dated31 January 2013
KeywordsMedicines Act 1981, New Medicine Consent, Tripacel, Vaccine
👩‍💼 Officials

Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Classification of Medicines

Domain🏥 Health & Social Welfare
Dated30 January 2013
KeywordsMedicines Act 1981, Medicine Classification, Prescription Medicines, Restricted Medicines, Pharmacy-only Medicines, General Sale Medicines
👩‍💼 Officials

Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

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